Non-Human Subject Research

What is Human Subject Research?

General Definition of Research (DHHS): A systematic investigation, including research development, testing, and evaluation,
designed to develop or contribute to generalizable knowledge.

A systematic investigation is an activity that is planned in advance and that uses data collection and analysis
to answer a question.

Generalizable knowledge is information that expands the knowledge base of a scientific discipline or other
scholarly field of study.

Definition of a Human Subject: A living individual about whom an investigator conducting research obtains

data through intervention or interaction with the individual, or

identifiable private information.

Intervention includes both physical procedures by which data are gathered and manipulations of
the subject or the subject's environment that are performed for research purposes.

FDA Definition of a Clinical Investigation: Use of a drug or medical device other than the use of an approved drug or medical
device in the course of medical practice, when data will be gathered, submitted to,
or held for inspection by the FDA in support of an FDA marketing permit for a food,
including a dietary supplement that bears a nutrient content claim or a health claim,
and infant formula, a food or color additive, a drug for human use, a medical device
for human use, a biological product for human use, or an electronic product.

General Definition of De-Identified (HIPAA): Information that does not identify an individual and with respect to which there
is no reasonable basis to believe that the information can be used to identify an
individual. This includes that there is no means to re-identify individuals after
the data have been de-identified (e.g., using a code or other means of record identification).
Generally, use of the Safe Harbor De-Identification standard ensures that data are de-identified.

What is Non-Human Subject Research?

Any project that does not involve research, a human subject, or a clinical investigation,
as defined above.

What are some examples of Non-Human Subject Research?

Projects that involve quality improvement, case reports, program evaluation, marketing
and related business analysis, and surveillance activities may not be considered human
subject research, so long as the project does not involve

A systematic investigation designed to develop or contribute to generalizable knowledge
using human subjects, or

Additionally, use of existing de-identified or publicly available datasets may not
be considered human subject research. For more information, see the following document:
Secondary Analysis of Existing Datasets.

The IRB uses the following guidances to determine if a project is or is not human
subject research:

What are the expectations when conducting a project that is Non-Human Subject Research?

Investigators are expected to adhere to ethical principles for non-human subject research
projects, including the following when appropriate:

Informed consent

Privacy and confidentiality protections

Sound design and procedures

Projects using protected health information (PHI) must still follow HIPAA regulations for authorization and confidentiality protections,
including projects using PHI about non-living individuals. Below are additional forms
that may be needed for these projects: